Enjoyable Occupation-Based Cognitive Stimulation With and Without Motivational Feedback in Parkinson's Disease: A Randomized Controlled Trial Protocol
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 90
研究概览
简要总结
Background: Cognitive impairment and psychological symptoms are highly prevalent in Parkinson's disease (PD) and significantly compromise daily functioning and quality of life. Occupation-based cognitive stimulation may enhance ecological validity and engagement, while motivational feedback could further improve adherence and neuroplasticity. However, the combined effects of these approaches have not been systematically examined in PD.
Objective: To evaluate the effects of enjoyable occupation-based cognitive stimulation with and without motivational feedback on cognitive, psychological, and occupational outcomes in older adults with PD and cognitive impairment.
Methods: This single-blind, three-arm randomized controlled trial will enroll 71 community-dwelling older adults with idiopathic PD. Participants will be randomly assigned to: (A) occupation-based cognitive stimulation with motivational feedback, (B) occupation-based cognitive stimulation without motivational feedback, or (C) gold standard of conventional occupational therapy. Interventions will consist of 12 supervised sessions over 6 weeks. The primary outcome is occupational performance measured by the Canadian Occupational Performance Measure (COPM). Secondary outcomes include global and Parkinson's disease-specific cognitive function (Montreal Cognitive Assessment [MoCA], Parkinson's Disease-Cognitive Rating Scale [PD-CRS], SCOPA-Cognition, Stroop Test, Clock Drawing Test, Trail Making Test), intrinsic motivation (Intrinsic Motivation Inventory), anxiety and depression (Hospital Anxiety and Depression Scale), apathy (Apathy Evaluation Scale, Lille Apathy Rating Scale, Dimensional Apathy Scale), quality of life (Parkinson's Disease Questionnaire-39), functional mobility (Timed Up and Go under single- and dual-task conditions), fear-related constructs (Tampa Scale of Kinesiophobia, Fear-Avoidance Components Scale, Falls Efficacy Scale-International), and flow experience during activities (Flow Short Scale and related occupational and rehabilitation flow measures). Assessments will be conducted at baseline, post-intervention, and follow-up. Data will be analyzed using linear mixed-effects models under an intention-to-treat framework.
Discussion: This trial will clarify the additive value of motivational feedback in occupation-based cognitive rehabilitation for PD. Findings may inform client-centered, ecologically valid rehabilitation strategies targeting non-motor symptoms in PD.
详细描述
Study objectives and hypotheses This trial aims to evaluate the effects of enjoyable occupation-based cognitive stimulation, with and without motivational feedback, on occupational performance, cognitive function, quality of life, functional mobility, and psychological symptoms (anxiety, apathy, fear-related constructs) in older adults with PD and cognitive impairment.
We hypothesize that:
Participants receiving cognitive stimulation with motivational feedback will demonstrate greater improvements in occupational performance, cognitive function, quality of life, and functional mobility than those receiving the same intervention without feedback.
Both intervention groups (with and without feedback) will show superior outcomes in occupational performance, cognition, and quality of life compared with conventional occupational therapy.
By integrating cognitive stimulation, enjoyment, and motivational mechanisms within an occupation-based framework, results from this study will be used to inform an intervention program and/or a larger-scale trial targeting non-motor symptoms in PD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Data will be collected by a research assistant who is an occupational therapist with six years of experience in neurological rehabilitation. The assistant will conduct eligibility screening and all outcome assessments at predefined time points and will remain blinded to group allocation, study purpose, treatment delivery, and randomization procedures.
Outcome assessors will remain blinded to group allocation throughout the study. Participants will be blinded to group allocation and specific study hypotheses. Unblinding is not anticipated; however, if required, access to allocation codes will be restricted to the trial steering committee, and all unblinding events will be documented.
Outcome assessments will be conducted by a blinded occupational therapist at baseline, post-intervention (6 weeks), and follow-up (12 weeks).
入排标准
- 年龄范围
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(a) have idiopathic PD diagnosed according to the UK Parkinson's Disease Society Brain Bank criteria; (b) have no history of impulsive-compulsive disorders, confirmed through neurologist-led clinical interviews; (c) are classified as Hoehn and Yahr stages I-IV; (d) are aged 60-80 years; (e) demonstrate mild-to-moderate cognitive impairment, defined as a Montreal Cognitive Assessment (MoCA) score of 21-25; and (f) are able to complete self-report measures.
排除标准
- •atypical parkinsonian syndromes, coexisting neurological disorders (e.g., stroke, other neurodegenerative diseases), and young-onset PD